Bristol-Myers Squibb Co. v. Boehringer Ingelheim Corp.

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BRISTOL-MYERS SQUIBB CO., Plaintiff, v. BOEHRINGER INGELHEIM CORP., BEN VENUE LABORATORIES, INC., and BEDFORD LABORATORIES, and IMMUNEX CORPORATION, and ZENITH GOLDLINE PHARMACEUTICALS, INC. and IVAX CORPORATION, and MYLAN PHARMACEUTICALS, INC. and MARSAM PHARMACEUTICALS, INC and SCHIEN PHARMACEUTICALS, INC. Defendants. and ZENITH GOLDLINE PHARMACEUTICALS, INC., IVAX CORPORATION, and BAKER NORTON PHARMACEUTICALS, Counterclaim Plaintiffs BRISTOL-MYERS SQUIBB COMPANY, Counterclaim Defendant.

Civil Action No. 97-6050.

Civil Action No. 97-6050 (WHW)

Civil Action No. 98-159 (WHW)

Civil Action No. 98-1412 (WHW)

Civil Action No. 98-1488 (WHW)

Civil Action No. 98-2827 (WHW)

Civil Action No. 98-1412 (WHW)

United States District Court, D. New Jersey.

Bristol/Taxol Counsel List, Jay B. Shapiro, Stearns Weaver Miller Weissler Aldhaff & Sitterson, Miami, FL.

Gerson Zweifach, Williams & Connolly, Washington DC.

William Mentlik, Lerner, David, Littenberg, Krumholz & Mentlik, Westfield, NJ.

H. Curtis Meanor, Podvey, Sachs, Meanor, Catenacci, Hildner & Cocoziello, Newark, NJ.

Martin Pavane, Cohen Pontani Lieberman & Pavane, New York, NY.

Charles Guttman, Proskauer Rose, New York, NY.

Frank Holahan, Harwood Lloyd, Hackensack, NJ.

William J. O'Shaughnessy, McCarter & English, Newark NJ.

Richard J. Stark, Cravath, Swaine & Moore, New York, NY.

Bruce Haas, Robert Baechtold, Fitzpatrick Cella, New York, NY.

Glenn Karta, Rothwell Figg, Washington DC.

OPINION

WILLIAM H. WALLS, D.J.

Defendants and counterclaimants Zenith Goldline Pharmaceuticals, IVAX Corporation, Baker Norton Pharmaceuticals, Immunex Corporation (collectively the "IVAX defendants") and Ben Venue Laboratories ("Ben Venue") move for summary judgment of invalidity of United States Patents Nos. 5,670,537 ("'537 patent") and 5,641,803 ("'803 patent") on the grounds of anticipation, 35 U.S.C. § 102(b), and obviousness, 35 U.S.C. § 103. Plaintiff Bristol-Myers Squibb ("Bristol") opposes the motions. The motions are granted in part.

Ben Venue's first motion for summary judgment of invalidity asserts that claims 1, 2, 5, 6, 8 and 9 of the '537 patent are invalid as anticipated or obvious by Mark Kris, et al., Phase I of Taxol Given as a 3-Hour Infusion Every 21 Days, 70 Cancer Treatment Reports 605-07 (1986) (the "Kris article"). Ben Venue further asserts that all claims of this patent are invalid as obvious from a written abstract ("OV.9 abstract") and oral presentation at an April 1991 meeting of the Clinical Trials Group of the National Cancer Institute of Canada ("NCIC"). Ben Venue's second motion for summary judgment of invalidity asserts that claims 1-3 and 6 of the '803 patent are anticipated by the Kris article and all claims of the '803 patent are anticipated by the OV.9 abstract. Zenith Goldline Pharmaceuticals, IVAX Corporation, Baker Norton Pharmaceuticals, and Immunex Corporation, in their motion, contend that claims 1-3 and 6 of the '803 patent and claims 1, 2, 5, and 8 of the '537 patent are anticipated by the Kris article; all claims of both patents are anticipated by the OV.9 abstract; and, all claims of both patents are invalid as obvious when the prior art, including but not limited to the Kris article and the OV.9 abstract, is considered in its entirety. Bristol responds that summary judgment is inappropriate and further argues that the prior art neither anticipates nor renders obvious the patents at issue.

Summary Judgment Standard

Patent cases are not immune to summary judgment motions. The Federal Circuit has "repeatedly emphasized that `summary judgment is as appropriate in a patent case as any other.'" Avia Group Int'l, Inc. v. L.A. Gear California, 853 F.2d 1557, 1561 (Fed. Cir. 1988). Summary judgment is appropriate where the moving party establishes that "there is no genuine issue of fact and that [it] is entitled to a judgment as a matter of law." Fed. R. Civ. P. 56. A factual dispute between the parties will not defeat a motion for summary judgment unless it is both genuine and material. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48 (1986). A factual dispute is genuine if a reasonable jury could return a verdict for the non-movant and it is material if, under the substantive law, it would affect the outcome of the suit. See id. at 248. The moving party must show that if the evidentiary material of record were reduced to admissible evidence in court, it would be insufficient to permit the non-moving party to carry its burden of proof. See Celotex v. Catrett, 477 U.S. 317, 318 (1986).

The party opposing a motion for summary judgment must set forth specific facts showing a genuine issue for trial and may not rest upon the mere allegations or denials of its pleadings. See Sound Phillip Ship Bldg. Co. v. Bethlehem Steel Co., 533 F.2d 96, 99 (3d Cir. 1976), cert. denied, 429 U.S. 860 (1976). At the summary judgment stage the court's function is not to weigh the evidence and determine the truth of the matter, but rather to determine whether there is a genuine issue for trial. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249 (1986). And, the court must construe the facts and inferences in the light most favorable to the non-moving party. See Wahl v. Rexnord, Inc. 624 F.2d 1169, 1181 (3d Cir. 1980).

Defendants, here, contend that certain claims of both patents in suit are invalid because they were anticipated or rendered obvious by prior art. 35 U.S.C. §§ 102(b) & 103. Since patent claims are presumptively valid, 35 U.S.C. § 282, defendants must advance clear and convincing evidence of invalidity in order to succeed. See generally Intel Corp. v. United States Int'l Trade Comm'n, 946 F.2d 821, 829 (Fed Cir. 1991); Tyler Refrigeration v. Kysor Indus. Corp., 777 F.2d 687, 690 (Fed. Cir. 1985).

Law of Anticipation

A patent is invalid as anticipated if:

the invention . . . was described in a printed publication in this or a foreign country . . . more than one year prior to the date of the application for the patent in the United States.

35 U.S.C. § 102(b). Under Section 102(b), inventions described in a "printed publication" distributed over one year before the initial patent application cannot be patented. The question of whether a document is a printed publication is "a legal determination based on underlying fact issues and, therefore, must be approached on a case-by-case basis." In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986). A document "disseminated or otherwise made available" "to persons concerned with the art to which the document relates" is a "printed publication." Massachusetts Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1109 (Fed. Cir. 1985); Carella v. Starlight Archery, 804 F.2d 135, 139 (Fed. Cir. 1986).

To invalidate an existing patent, a single prior publication must contain all of the essential limitations of each claim; there must be identity between the claimed process and a process described in a prior art reference. See Glaverbel Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550, 1554 (Fed. Cir. 1995); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379 (Fed. Cir. 1986). Defendants must show that "each element of the claim in issue is found in a prior patent or publication, either expressly or under principles of inherency." Tyler Refrigeration v. Kysor Indus. Corp., 777 F.2d 687, 689 (Fed. Cir. 1985); see also Celeritas Tech. Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354, 1360 (Fed. Cir. 1998); Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631-32 (Fed. Cir. 1987). Inherency occurs when the invention described by the prior art necessarily functions in accordance with a claim limitation, even if the limitation is not expressly mentioned in the art. See generally Robert Harmon, Patents and the Federal Circuit § 3.2 (4th ed. 1999).

Claim anticipation in prior art is a finding of fact. See Titanium Metals Corp. v. Banner, 778 F.2d 775, 780-782 (Fed. Cir. 1985); Ecolochem, Inc. v. Southern California Edison Co., 863 F. Supp. 1165, 1179 (C.D. Cal. 1994), aff'd in part, rev'd in part, 91 F.3d 169 (Fed. Cir. 1996) ("Whether a [prior art] reference discloses each element of the claim is a question of fact."). Defendants' motions, then, can only be granted if there are no genuine disputes of material fact whether the processes described in any one of the articles submitted anticipate the patents' claims.

The prior art need not present the invention in a positive light, so long as all claims are explicitly or inherently contained in the publication. See Celeritas, 150 F.3d at 1361 ("A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it. . . . the question of whether a reference `teaches away' from the invention is inapplicable to an anticipation analysis."); see also Kalman v. Kimberly Clark Corp., 713 F.2d 760, 772 (Fed. Cir. 1983), overruled on other grounds, SRI Intern. v. Matsushita Elec. Corp., 775 F.2d 1107 (Fed. Cir. 1985) ("The law of anticipation does not require that the reference `teach' what the subject patent teaches."); Merck & Co. v. Mylan Pharm., Inc., 19 F. Supp. 2d 334, 345-46 (E.D. Pa. 1998); see generally Lance L. Barry, Teaching A Way Is Not Teaching Away, 79 J. Pat. & Trade. Off. Soc'y 867, 869 (1997) (a reference teaches away when "it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant."). The invention as disclosed by the prior art, however, must be described so as to "enable" one skilled in the art to (1) identify all claim limitations and (2) create the invention.¹

Thus, anticipation analysis is a three-step process. The first step is claim construction. The claims of the two patents in suit are constructed in a companion opinion (the "Markman Opinion"). The second step requires the Court to compare the properly constructed claims with the subject matter described in the prior art...